Safety and Immunogenicity of MF59C.1 Adjuvanted Trivalent... | NCT01162122

Label	Type	Description	Intervention Names
aTIV	Experimental	Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).	Biological: MF59 adjuvanted trivalent subunit influenza vaccine (aTIV)
Licensed TIV	Experimental	Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).	Biological: Non-adjuvanted trivalent subunit influenza vaccine (TIV)

Name	Type	Description	Arm Group Labels	Other Names
MF59 adjuvanted trivalent subunit influenza vaccine (aTIV)	Biological	one dose 0.5 mL administered IM in the deltoid muscle of (preferably) the non-dominant arm	aTIV

Measure	Description	Time Frame
Geometric Mean Titers in Subjects After Receiving One Dose of Lot 1 or Lot 2 or Lot 3 of aTIV	Immunologic equivalence of 3 consecutive production lots of aTIV (Lot 1, Lot 2 and Lot 3), was assessed in terms of Hemagglutination Inhibition (HI) Geometric Mean Titers (GMTs) in subjects, at three weeks after vaccination, against each vaccine strain.	Day 22 post vaccination
Comparison of aTIV Versus TIV in Terms of Geometric Mean Titers (GMTs) Against Homologous Strains - PPS	The non-inferiority of HI antibody responses of aTIV compared to TIV assessed in terms of post vaccination GMTs at three weeks after vaccination against the three homologous vaccine strains.	Day 22 post vaccination
Comparison of aTIV Versus TIV in Terms of Percentage of Subjects Achieving Seroconversion Against Homologous Strains-PPS	The non-inferiority of HI antibody responses of aTIV compared to TIV assessed in terms of percentage of subjects achieving seroconversion at three weeks after vaccination against the three homologous vaccine strains. Seroconversion defined as prevaccination HI titer <10 and postvaccination HI titer ≥40 or at least a 4-fold increase in HI titers from prevaccination HI titer ≥10.	Day 22 post vaccination
Comparison of aTIV Versus TIV in Terms of GMTs Against Homologous Strains-Full Analysis Set (FAS)	The superiority of HI antibody responses of aTIV compared to TIV assessed in terms of post vaccination GMTs at three weeks after vaccination against the three homologous vaccine strains.	Day 22 post vaccination
Comparison of aTIV Versus TIV in Terms of Percentage of Subjects Achieving Seroconversion Against Homologous Strains-FAS	The superiority of HI antibody responses of aTIV compared to TIV assessed in terms of percentage of subjects achieving seroconversion at three weeks after vaccination against the three homologous vaccine strains. Seroconversion defined as prevaccination HI titer <10 and postvaccination HI titer ≥40 or at least a 4-fold increase in HI titers from prevaccination HI titer ≥10.

Measure	Description	Time Frame
Comparison of aTIV Versus TIV in High Risk Group in Terms of GMTs Against Homologous Strains-PPS	The non-inferiority of HI antibody responses of ATIV compared to TIV, in subjects with pre-defined co-morbidities (high risk subjects), was assessed in terms of post vaccination GMTs at three weeks after vaccination against the three homologous vaccine strains.	Day 22 post vaccination

Name	Affiliation	Role
Novartis Vaccines	Novartis Vaccines	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
301, Tatum Highlands Medical Associates PLLC, 26224 N Tatum Blvd 15A		Phoenix	Arizona	85253	United States

PubMed Identifier	Type	Citation	Retractions
25045825	Derived	Frey SE, Reyes MR, Reynales H, Bermal NN, Nicolay U, Narasimhan V, Forleo-Neto E, Arora AK. Comparison of the safety and immunogenicity of an MF59(R)-adjuvanted with a non-adjuvanted seasonal influenza vaccine in elderly subjects. Vaccine. 2014 Sep 3;32(39):5027-34. doi: 10.1016/j.vaccine.2014.07.013. Epub 2014 Jul 18.

ID	Title	Description
FG000	aTIV (Pooled)	Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
FG001	Licensed TIV

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Geometric Mean Titers in Subjects After Receiving One Dose of Lot 1 or Lot 2 or Lot 3 of aTIV

Immunologic equivalence of 3 consecutive production lots of aTIV (Lot 1, Lot 2 and Lot 3), was assessed in terms of Hemagglutination Inhibition (HI) Geometric Mean Titers (GMTs) in subjects, at three weeks after vaccination, against each vaccine strain.

Analysis was done on the per protocol set population (PPS) i.e all randomised subjects who received the correct vaccine, provided evaluable serum samples, and had no major protocol deviation prior to unblinding.

Posted

Geometric Mean

95% Confidence Interval

Titers

Day 22 post vaccination

ID	Title	Description
OG000	aTIV_Lot 1	Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from Lot 1
OG001	aTIV_Lot 2	Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from Lot 2
OG002	aTIV_Lot 3	Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from Lot 3

Units	Counts
Participants	OG0001073 OG0011078 OG0021076

Title

Denominators

Categories

H1N1 strain (N=1072,1078,1075)

Title	Measurements
	OG000209(189 to 231) OG001187(170 to 207) OG002199(180 to 220)

H3N2 strain (N=1072,1078,1075)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001						GMT ratio (H1N1 strain)	1.12			2-Sided	95	1	1.24				Yes	Non-Inferiority or Equivalence	The 95% CIs of GMT ratios for the pairwise lot-to-lot group comparisons should fall within the equivalence range of 0.67 to 1.5.
OG000 OG002

Primary

Comparison of aTIV Versus TIV in Terms of Geometric Mean Titers (GMTs) Against Homologous Strains - PPS

The non-inferiority of HI antibody responses of aTIV compared to TIV assessed in terms of post vaccination GMTs at three weeks after vaccination against the three homologous vaccine strains.

Analysis was done on PPS.

Posted

Geometric Mean

95% Confidence Interval

Titers

Day 22 post vaccination

ID	Title	Description
OG000	aTIV (Pooled)	Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
OG001	Licensed TIV	Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).

Units	Counts
Participants	OG000

Primary

Comparison of aTIV Versus TIV in Terms of Percentage of Subjects Achieving Seroconversion Against Homologous Strains-PPS

The non-inferiority of HI antibody responses of aTIV compared to TIV assessed in terms of percentage of subjects achieving seroconversion at three weeks after vaccination against the three homologous vaccine strains.

Seroconversion defined as prevaccination HI titer <10 and postvaccination HI titer ≥40 or at least a 4-fold increase in HI titers from prevaccination HI titer ≥10.

Analysis was done on PPS.

Posted

Number

95% Confidence Interval

Percentage of subjects

Day 22 post vaccination

ID	Title	Description
OG000	aTIV (Pooled)	Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
OG001	Licensed TIV	Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).

Units	Counts
Participants

Primary

Comparison of aTIV Versus TIV in Terms of GMTs Against Homologous Strains-Full Analysis Set (FAS)

The superiority of HI antibody responses of aTIV compared to TIV assessed in terms of post vaccination GMTs at three weeks after vaccination against the three homologous vaccine strains.

Analysis was done on FAS i.e all randomized subjects who received a study vaccination and provided evaluable serum samples both at day 1 and at day 22

Posted

Geometric Mean

95% Confidence Interval

Titers

Day 22 post vaccination

ID	Title	Description
OG000	aTIV (Pooled)	Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
OG001	Licensed TIV	Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).

Units	Counts
Participants	OG000

Primary

Comparison of aTIV Versus TIV in Terms of Percentage of Subjects Achieving Seroconversion Against Homologous Strains-FAS

The superiority of HI antibody responses of aTIV compared to TIV assessed in terms of percentage of subjects achieving seroconversion at three weeks after vaccination against the three homologous vaccine strains.

Seroconversion defined as prevaccination HI titer <10 and postvaccination HI titer ≥40 or at least a 4-fold increase in HI titers from prevaccination HI titer ≥10.

Analysis was done on FAS.

Posted

Number

95% Confidence Interval

Percentage of subjects

Day 22 post vaccination

ID	Title	Description
OG000	aTIV (Pooled)	Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
OG001	Licensed TIV	Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).

Units	Counts
Participants

Primary

Percentage of Subjects With HI Titers ≥40 Against Homologous Strains

The percentage of subjects demonstrating HI titers ≥40, in overall group and in subjects with pre-defined co-morbidities (high risk group), against homologous strains, three weeks after vaccination with aTIV or TIV.

Analysis was done on the FAS.

Posted

Number

95% Confidence Interval

Percentage of subjects

Day 22 post vaccination

ID	Title	Description
OG000	aTIV (Pooled)	Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
OG001	Licensed TIV	Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).

Units	Counts
Participants	OG000

Primary

Percentage of Subjects Achieving Seroconversion in HI Titers, Against Homologous Strains

The percentage of subjects achieving seroconversion in HI titers from baseline, in overall group and in subjects with pre-defined co-morbidities (high risk group), against homologous strains, three weeks after vaccination with aTIV or TIV.

Seroconversion is defined as prevaccination HI titer <10 and postvaccination HI titer ≥40 or at least a 4-fold increase in HI titers from prevaccination HI titer ≥10.

Analysis was done on the FAS.

Posted

Number

95% Confidence Interval

Percentage of subjects

Day 22 post vaccination

ID	Title	Description
OG000	aTIV (Pooled)	Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
OG001	Licensed TIV	Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).

Units	Counts
Participants

Primary

Geometric Mean Ratio (GMR) of Post- Versus Pre-vaccination HI Titers Against Homologous Strains

The GMR of post-vaccination versus pre-vaccination HI titers (day 22/day 1) in overall group and in subjects with pre-defined co-morbidities (high risk group), against homologous strains, three weeks after vaccination with aTIV or TIV.

Analysis was done on the FAS

Posted

Geometric Mean

95% Confidence Interval

Ratio

Day 22 post vaccination

ID	Title	Description
OG000	aTIV (Pooled)	Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
OG001	Licensed TIV	Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).

Units	Counts
Participants	OG000

Secondary

Comparison of aTIV Versus TIV in High Risk Group in Terms of GMTs Against Homologous Strains-PPS

The non-inferiority of HI antibody responses of ATIV compared to TIV, in subjects with pre-defined co-morbidities (high risk subjects), was assessed in terms of post vaccination GMTs at three weeks after vaccination against the three homologous vaccine strains.

Analysis was done on PPS.

Posted

Geometric Mean

95% Confidence Interval

Titers

Day 22 post vaccination

ID	Title	Description
OG000	aTIV (Pooled)	Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
OG001	Licensed TIV	Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).

Units	Counts
Participants	OG000

Secondary

Comparison of HI Antibody Responses of aTIV Versus TIV, in High Risk Group in Terms of Percentage of Subjects Achieving Seroconversion Against Homologous Strains-PPS

The non-inferiority of HI antibody responses of ATIV compared to TIV, in subjects with pre-defined co-morbidities (high risk group), assessed in terms of percentage of subjects achieving seroconversion at three weeks after vaccination against the homologous vaccine strains.

Seroconversion is defined as prevaccination HI titer <10 and postvaccination HI titer ≥40 or at least a 4-fold increase in HI titers from prevaccination HI titer ≥10.

Analysis was done on PPS.

Posted

Number

95% Confidence Interval

Percentage of subjects

Day 22 post vaccination

ID	Title	Description
OG000	aTIV (Pooled)	Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
OG001	Licensed TIV	Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).

Units	Counts
Participants

Secondary

Comparison of aTIV Versus TIV in High Risk Group in Terms of GMTs Against Homologous Strains-FAS

The superiority of HI antibody responses of aTIV compared to TIV, in subjects with predefined co-morbidities (high risk group) assessed in terms of post vaccination GMTs at three weeks after vaccination against the three homologous vaccine strains.

Analysis was done on FAS population.

Posted

Geometric Mean

95% Confidence Interval

Titers

Day 22 post vaccination

ID	Title	Description
OG000	aTIV (Pooled)	Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
OG001	Licensed TIV	Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).

Units	Counts
Participants	OG000

Primary

Percentage of Subjects With HI Titers ≥40 Against Heterologous Strains

The percentage of subjects demonstrating HI titers ≥40, in overall group and in subjects with pre-defined co-morbidities (high risk group), against heterologous strains, three weeks after vaccination with aTIV or TIV.

Analysis was done on the FAS.

Posted

Number

95% Confidence Interval

Percentage of subjects

Day 22 post vaccination

ID	Title	Description
OG000	aTIV (Pooled)	Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
OG001	Licensed TIV	Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).

Units	Counts
Participants	OG000

Primary

Geometric Mean Ratio (GMR) of Post- Versus Pre-vaccination HI Titers, Against Heterologous Strains

The GMR of post-vaccination versus pre-vaccination HI titers (day 22/day 1) in overall group and in subjects with pre-defined co-morbidities (high risk group), against heterologous strains, three weeks after vaccination with aTIV or TIV.

Analysis was done on the FAS.

Posted

Geometric Mean

95% Confidence Interval

Ratio

Day 22 post vaccination

ID	Title	Description
OG000	aTIV (Pooled)	Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
OG001	Licensed TIV	Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).

Units	Counts
Participants	OG000

Primary

Percentage of Subjects Achieving Seroconversion in HI Titers, Against Heterologous Strains

The percentage of subjects achieving seroconversion in HI titers from baseline, in overall group and in subjects with pre-defined co-morbidities (high risk group), against heterologous strains, three weeks after vaccination with aTIV or TIV.

Seroconversion is defined as prevaccination HI titer <10 and postvaccination HI titer ≥40 or at least a 4-fold increase in HI titers from prevaccination HI titer ≥10.

Analysis was done on the FAS.

Posted

Number

95% Confidence Interval

Percentage of subjects

Day 22 post vaccination

ID	Title	Description
OG000	aTIV (Pooled)	Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
OG001	Licensed TIV	Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).

Units	Counts
Participants

Secondary

Comparison of HI Antibody Responses of aTIV Versus TIV, in High Risk Group in Terms of Percentage of Subjects Achieving Seroconversion Against Homologous Strains-FAS

The superiority of HI antibody responses of aTIV compared to TIV, in subjects with pre-defined co-morbidities (high risk group), assessed in terms of percentage of subjects achieving seroconversion at three weeks after vaccination against the homologous vaccine strains.

Seroconversion is defined as prevaccination HI titer <10 and postvaccination HI titer ≥40 or at least a 4-fold increase in HI titers from prevaccination HI titer ≥10.

Analysis was done on FAS.

Posted

Number

95% Confidence Interval

Percentage of subjects

Day 22 postvaccination

ID	Title	Description
OG000	aTIV (Pooled)	Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
OG001	Licensed TIV	Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).

Units	Counts
Participants

Secondary

Comparison of aTIV Versus TIV in Terms of GMTs Against Heterologous Strains-PPS

The non-inferiority of HI antibody responses of aTIV compared to TIV against the heterologous vaccine strains, in overall group and in subjects with pre-defined co-morbidities (high risk subjects), was assessed in terms of post vaccination GMTs at three weeks after vaccination .

Analysis was done on PPS.

Posted

Geometric Mean

95% Confidence Interval

Titers

Day 22 post vaccination

ID	Title	Description
OG000	aTIV (Pooled)	Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
OG001	Licensed TIV	Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).

Units	Counts
Participants	OG000

Secondary

Comparison of aTIV Versus TIV in Terms of GMTs Against Heterologous Strains-FAS

The superiority of HI antibody responses of aTIV compared to TIV against the heterologous vaccine strains, in overall group and in subjects with pre-defined co-morbidities (high risk subjects), was assessed in terms of post vaccination GMTs at three weeks after vaccination.

Analysis was done on FAS.

Posted

Geometric Mean

95% Confidence Interval

Titers

Day 22 post vaccination

ID	Title	Description
OG000	aTIV (Pooled)	Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
OG001	Licensed TIV	Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).

Units	Counts
Participants	OG000

Secondary

Comparison of HI Antibody Responses of aTIV Versus TIV, in Terms of Percentage of Subjects Achieving Seroconversion Against Heterologous Strains-PPS

The non-inferiority of HI antibody responses of aTIV compared to TIV against the heterologous strains, in overall group and in subjects with pre-defined co-morbidities (high risk group), assessed in terms of percentage of subjects achieving seroconversion at three weeks after vaccination.

Seroconversion is defined as prevaccination HI titer <10 and postvaccination HI titer ≥40 or at least a 4-fold increase in HI titers from prevaccination HI titer ≥10.

Analysis was done on PPS.

Posted

Number

95% Confidence Interval

Percentage of subjects

Day 22 postvaccination

ID	Title	Description
OG000	aTIV (Pooled)	Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
OG001	Licensed TIV	Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).

Units	Counts
Participants

Secondary

Comparison of aTIV Versus TIV in Terms of Percentage of Subjects Achieving Seroconversion Against Heterologous Strains-FAS

The superiority of HI antibody responses of aTIV compared to TIV against the heterologous vaccine strains, in overall group and in subjects with pre-defined co-morbidities (high risk subjects), was assessed in terms of percentage of subjects achieving seroconversion, at three weeks after vaccination.

Seroconversion is defined as prevaccination HI titer <10 and postvaccination HI titer ≥40 or at least a 4-fold increase in HI titers from prevaccination HI titer ≥10.

Analysis was done on FAS

Posted

Number

95% Confidence Interval

Percentage of subjects

Day 22 post vaccination

ID	Title	Description
OG000	aTIV (Pooled)	Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
OG001	Licensed TIV	Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).

Units	Counts
Participants

Secondary

Persistence of GMTs Against Homologous and Heterologous Strains

The GMTs against homologous and heterologous strains, persisting in subjects at six months (day 181) and one year (day 366) after vaccination with either aTIV or TIV.

The analysis was done on the FAS (persistence) subset population i.e all randomized population only from US sites who received a study vaccination, provided evaluable blood samples at day 1, day 22, day 181, and day 366.

Posted

Geometric Mean

95% Confidence Interval

Titers

Day 181, Day 366 post vaccination

ID	Title	Description
OG000	aTIV (Pooled)	Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
OG001	Licensed TIV	Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).

Units	Counts
Participants	OG000

Secondary

Percentage of Subjects With Seroconversion Upto One Year After Vaccination, Against Homologous and Heterologous Strains

The percentage of subjects demonstrating seroconversion in HI titers against homologous and heterologous strains, at six months (day 181) and one year (day 366) after vaccination with either aTIV or TIV.

Seroconversion is defined as prevaccination HI titer <10 and postvaccination HI titer ≥40 or at least a 4-fold increase in HI titers from prevaccination HI titer ≥10.

The analysis was done on the FAS (persistence) subset.

Posted

Number

95% Confidence Interval

Percentage of subjects

Day 181, Day 366 post vaccination

ID	Title	Description
OG000	aTIV (Pooled)	Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
OG001	Licensed TIV	Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).

Units	Counts
Participants

Secondary

Number of Subjects Reporting Influenza Like Illness (ILI) Across Vaccine Groups

The number of subjects reporting ILI from three weeks after vaccination to up to one year in aTIV group compared to TIV group, by country.

Analysis was done on the modified full analysis set (mFAS; effectiveness) population i.e all subjects in the randomized population who received a study vaccination but excluding those who received a non-study vaccine during the follow-up phase.

Posted

Number

participants

Day 22 through Day 366 post vaccination

ID	Title	Description
OG000	aTIV (Pooled)	Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
OG001	Licensed TIV	Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).

Units	Counts
Participants	OG000

Secondary

Number of High Risk Subjects With Exacerbation of Preexisting Chronic Disease, Across Vaccine Groups

The number of high risk subjects reporting exacerbation of preexisting chronic conditions (i.e.congestive heart failure, Chronic Obstructive Pulmonary disease (COPD), asthma, hepatic disease, renal insufficiency, and neurological/neuromuscular or metabolic disorders including diabetes mellitus) in aTIV group compared to TIV group.

Analysis was done on the mFAS (effectiveness) population.

Posted

Number

participants

Day 1 through Day 366 post vaccination

ID	Title	Description
OG000	aTIV (Pooled)	Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
OG001	Licensed TIV	Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).

Units	Counts
Participants	OG000

Secondary

Number of Subjects Reporting Healthcare Utilization Across Vaccine Groups

The number of subjects with emergency room visits, unscheduled physician visits, and hospitalizations due to community acquired influenza or pneumonia, cardiopulmonary disease, cardiac disease, respiratory or pulmonary disease,in aTIV group compared to TIV group.

Analysis was done on the mFAS (effectiveness).

Posted

Number

participants

Day 1 through Day 366 post vaccination

ID	Title	Description
OG000	aTIV (Pooled)	Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
OG001	Licensed TIV	Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).

Units	Counts
Participants	OG000

Secondary

All Cause Mortality Rate, Across Vaccine Groups

The all-cause mortality rate (excluding injury)reported in aTIV group compared to TIV group, by country.

Analysis was done on the mFAS (effectiveness).

Posted

Number

participants

Day 1 through Day 366 post vaccination

ID	Title	Description
OG000	aTIV (Pooled)	Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
OG001	Licensed TIV	Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).

Units	Counts
Participants	OG000

Secondary

Number of Subjects Reporting Solicited Adverse Events Following Vaccination

The number of subjects reporting solicited local and systemic adverse events and other adverse events in aTIV group compared to TIV group.

Analysis was done on the safety set i.e all randomized subjects who received a study vaccination and provided postvaccination safety data.

Posted

Number

participants

Day 1 through Day 7 post vaccination

ID	Title	Description
OG000	aTIV (Pooled)	Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
OG001	Licensed TIV	Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anemia	Blood and lymphatic system disorders	MedDRA	Non-systematic Assessment	EG0002 affected3,545 at risk EG0015 affected3,537 at risk
Disseminated intravascular coagulation	Blood and lymphatic system disorders	MedDRA	Non-systematic Assessment	EG0001 affected3,545 at risk EG0010 affected3,537 at risk
Idiopathic Thrombocytopenic coagulation	Blood and lymphatic system disorders	MedDRA	Non-systematic Assessment	EG0001 affected3,545 at risk EG0010 affected3,537 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA	Non-systematic Assessment	EG0000 affected3,545 at risk EG0011 affected3,537 at risk
Sideroblastic anaemia	Blood and lymphatic system disorders	MedDRA	Non-systematic Assessment	EG0001 affected3,545 at risk EG0010 affected3,537 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0002 affected3,545 at risk EG0010 affected3,537 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA	Non-systematic Assessment	EG00011 affected3,545 at risk EG0017 affected3,537 at risk
Angina pectoris	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0001 affected3,545 at risk EG0012 affected3,537 at risk
Angina unstable	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0003 affected3,545 at risk EG0011 affected3,537 at risk
Arrhythmia	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0000 affected3,545 at risk EG0012 affected3,537 at risk
Arteriosclerosis coronary artery	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0002 affected3,545 at risk EG0010 affected3,537 at risk
Atrial Fibrillation	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0004 affected3,545 at risk EG0018 affected3,537 at risk
Atrial tachycardia	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0001 affected3,545 at risk EG0010 affected3,537 at risk
Bradycardia	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0002 affected3,545 at risk EG0010 affected3,537 at risk
Cardiac arrest	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0000 affected3,545 at risk EG0012 affected3,537 at risk
Cardiac disorder	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0002 affected3,545 at risk EG0010 affected3,537 at risk
Cardiac failure	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0003 affected3,545 at risk EG0014 affected3,537 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0008 affected3,545 at risk EG00116 affected3,537 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0003 affected3,545 at risk EG0011 affected3,537 at risk
Cardiogenic shock	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0000 affected3,545 at risk EG0011 affected3,537 at risk
Coronary artery disease	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0007 affected3,545 at risk EG0016 affected3,537 at risk
Dressler's syndrome	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0001 affected3,545 at risk EG0010 affected3,537 at risk
Hypertensive heart disease	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0002 affected3,545 at risk EG0011 affected3,537 at risk
Hypertrophic cardiomyopathy	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0000 affected3,545 at risk EG0011 affected3,537 at risk
Myocardial infarction	Cardiac disorders	MedDRA	Non-systematic Assessment	EG00010 affected3,545 at risk EG0019 affected3,537 at risk
Myocardial Ischemia	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0003 affected3,545 at risk EG0012 affected3,537 at risk
Nodal arrythmia	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0001 affected3,545 at risk EG0010 affected3,537 at risk
Pericarditis	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0001 affected3,545 at risk EG0010 affected3,537 at risk
Sinus Tachycardia	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0001 affected3,545 at risk EG0010 affected3,537 at risk
Ventricular extrasystoles	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0002 affected3,545 at risk EG0010 affected3,537 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0001 affected3,545 at risk EG0011 affected3,537 at risk
Hydrocele	Congenital, familial and genetic disorders	MedDRA	Non-systematic Assessment	EG0001 affected3,545 at risk EG0011 affected3,537 at risk
Vertigo	Ear and labyrinth disorders	MedDRA	Non-systematic Assessment	EG0001 affected3,545 at risk EG0011 affected3,537 at risk
Vertigo positional	Ear and labyrinth disorders	MedDRA	Non-systematic Assessment	EG0002 affected3,545 at risk EG0011 affected3,537 at risk
Blindness unilateral	Eye disorders	MedDRA	Non-systematic Assessment	EG0000 affected3,545 at risk EG0011 affected3,537 at risk
Corneal degeneration	Eye disorders	MedDRA	Non-systematic Assessment	EG0000 affected3,545 at risk EG0011 affected3,537 at risk
Retinal neovascularisation	Eye disorders	MedDRA	Non-systematic Assessment	EG0000 affected3,545 at risk EG0011 affected3,537 at risk
Viterous hemorrhage	Eye disorders	MedDRA	Non-systematic Assessment	EG0000 affected3,545 at risk EG0011 affected3,537 at risk
Abdominal hernia	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected3,545 at risk EG0010 affected3,537 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected3,545 at risk EG0011 affected3,537 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected3,545 at risk EG0011 affected3,537 at risk
Abdominal wall hematoma	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected3,545 at risk EG0011 affected3,537 at risk
Ascites	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected3,545 at risk EG0010 affected3,537 at risk
Colitis	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected3,545 at risk EG0011 affected3,537 at risk
Diverticular perforation	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected3,545 at risk EG0011 affected3,537 at risk
Diverticulum	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected3,545 at risk EG0012 affected3,537 at risk
Duodenal ulcer perforation	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected3,545 at risk EG0011 affected3,537 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected3,545 at risk EG0011 affected3,537 at risk
Erosive oesophagitis	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected3,545 at risk EG0010 affected3,537 at risk
Femoral hernia,obstructive	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected3,545 at risk EG0010 affected3,537 at risk
Gastric ulcer perforation	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected3,545 at risk EG0011 affected3,537 at risk
Gastritis	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected3,545 at risk EG0011 affected3,537 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0002 affected3,545 at risk EG0011 affected3,537 at risk
Hiatus hernia	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected3,545 at risk EG0011 affected3,537 at risk
Ileus	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected3,545 at risk EG0011 affected3,537 at risk
Ileus paralytic	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected3,545 at risk EG0011 affected3,537 at risk
Inguinal hernia, obstructive	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected3,545 at risk EG0011 affected3,537 at risk
Intestinal perforation	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected3,545 at risk EG0010 affected3,537 at risk
Irritable bowel syndrome	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected3,545 at risk EG0010 affected3,537 at risk
Large intestine perforation	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected3,545 at risk EG0010 affected3,537 at risk
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected3,545 at risk EG0011 affected3,537 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected3,545 at risk EG0010 affected3,537 at risk
Pancreatic mass	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected3,545 at risk EG0010 affected3,537 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0004 affected3,545 at risk EG0010 affected3,537 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected3,545 at risk EG0011 affected3,537 at risk
Peptic ulcer	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected3,545 at risk EG0014 affected3,537 at risk
Peptic ulcer perforation	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected3,545 at risk EG0010 affected3,537 at risk
Pneumoperitonium	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected3,545 at risk EG0011 affected3,537 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected3,545 at risk EG0011 affected3,537 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected3,545 at risk EG0014 affected3,537 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0004 affected3,545 at risk EG0017 affected3,537 at risk
Volvulus	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected3,545 at risk EG0010 affected3,537 at risk
Chest pain	General disorders	MedDRA	Non-systematic Assessment	EG0007 affected3,545 at risk EG0013 affected3,537 at risk
Hernia obstructive	General disorders	MedDRA	Non-systematic Assessment	EG0000 affected3,545 at risk EG0011 affected3,537 at risk
Multi-organ failure	General disorders	MedDRA	Non-systematic Assessment	EG0003 affected3,545 at risk EG0011 affected3,537 at risk
Non-cardiac chest pain	General disorders	MedDRA	Non-systematic Assessment	EG0001 affected3,545 at risk EG0011 affected3,537 at risk
Pyrexia	General disorders	MedDRA	Non-systematic Assessment	EG0001 affected3,545 at risk EG0012 affected3,537 at risk
Bile duct stone	Hepatobiliary disorders	MedDRA	Non-systematic Assessment	EG0001 affected3,545 at risk EG0010 affected3,537 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA	Non-systematic Assessment	EG0007 affected3,545 at risk EG0012 affected3,537 at risk
Cholecystitis chronic	Hepatobiliary disorders	MedDRA	Non-systematic Assessment	EG0001 affected3,545 at risk EG0010 affected3,537 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA	Non-systematic Assessment	EG0004 affected3,545 at risk EG0014 affected3,537 at risk
Chronic hepatic failure	Hepatobiliary disorders	MedDRA	Non-systematic Assessment	EG0001 affected3,545 at risk EG0010 affected3,537 at risk
Hepatic cirrhosis	Hepatobiliary disorders	MedDRA	Non-systematic Assessment	EG0001 affected3,545 at risk EG0010 affected3,537 at risk
Jaundice	Hepatobiliary disorders	MedDRA	Non-systematic Assessment	EG0000 affected3,545 at risk EG0011 affected3,537 at risk
Drug hypersensitivity	Immune system disorders	MedDRA	Non-systematic Assessment	EG0001 affected3,545 at risk EG0010 affected3,537 at risk
Appendicitis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected3,545 at risk EG0012 affected3,537 at risk
Arthritis bacterial	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected3,545 at risk EG0011 affected3,537 at risk
Arthritis infective	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected3,545 at risk EG0011 affected3,537 at risk
Bronchitis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0005 affected3,545 at risk EG0011 affected3,537 at risk
Cellulitis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0002 affected3,545 at risk EG0013 affected3,537 at risk
Cellulitis staphylococcal	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected3,545 at risk EG0010 affected3,537 at risk
Cystitis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected3,545 at risk EG0011 affected3,537 at risk
Diverticulitis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected3,545 at risk EG0012 affected3,537 at risk
Escherichia sepsis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected3,545 at risk EG0010 affected3,537 at risk
Gastroenteritis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0005 affected3,545 at risk EG0016 affected3,537 at risk
Gastroenteritis viral	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected3,545 at risk EG0011 affected3,537 at risk
Herpes zoster	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected3,545 at risk EG0011 affected3,537 at risk
Incision site infection	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected3,545 at risk EG0011 affected3,537 at risk
Infected skin ulcer	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected3,545 at risk EG0010 affected3,537 at risk
Infectious peritonitis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected3,545 at risk EG0011 affected3,537 at risk
Laryngitis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected3,545 at risk EG0010 affected3,537 at risk
Leptospirosis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected3,545 at risk EG0010 affected3,537 at risk
Lobar pneumonia	Infections and infestations	MedDRA	Non-systematic Assessment	EG0002 affected3,545 at risk EG0011 affected3,537 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected3,545 at risk EG0011 affected3,537 at risk
Meningitis aseptic	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected3,545 at risk EG0011 affected3,537 at risk
Peritonsillar abscess	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected3,545 at risk EG0011 affected3,537 at risk
Pneumonia	Infections and infestations	MedDRA	Non-systematic Assessment	EG00032 affected3,545 at risk EG00135 affected3,537 at risk
Pneumonia viral	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected3,545 at risk EG0010 affected3,537 at risk
Pulmonary Tuberculosis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0002 affected3,545 at risk EG0012 affected3,537 at risk
Pyelonephritis acute	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected3,545 at risk EG0011 affected3,537 at risk
Sepsis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0003 affected3,545 at risk EG0012 affected3,537 at risk
Septic shock	Infections and infestations	MedDRA	Non-systematic Assessment	EG0003 affected3,545 at risk EG0013 affected3,537 at risk
Staphylococcal infection	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected3,545 at risk EG0011 affected3,537 at risk
Streptococcal sepsis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected3,545 at risk EG0011 affected3,537 at risk
Tetanus	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected3,545 at risk EG0011 affected3,537 at risk
Tracheobronchitis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected3,545 at risk EG0010 affected3,537 at risk
Tuberculosis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected3,545 at risk EG0010 affected3,537 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected3,545 at risk EG0010 affected3,537 at risk
Urinary tract infection	Infections and infestations	MedDRA	Non-systematic Assessment	EG0008 affected3,545 at risk EG0016 affected3,537 at risk
Urosepsis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected3,545 at risk EG0011 affected3,537 at risk
Wound abscess	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected3,545 at risk EG0011 affected3,537 at risk
Back injury	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0001 affected3,545 at risk EG0010 affected3,537 at risk
Brain herniation	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0000 affected3,545 at risk EG0011 affected3,537 at risk
Clavicle fracture	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0000 affected3,545 at risk EG0011 affected3,537 at risk
Concussion	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0001 affected3,545 at risk EG0010 affected3,537 at risk
Craniocerebral injury	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0000 affected3,545 at risk EG0011 affected3,537 at risk
Facial bones fracture	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0000 affected3,545 at risk EG0011 affected3,537 at risk
Fall	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0001 affected3,545 at risk EG0010 affected3,537 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0002 affected3,545 at risk EG0011 affected3,537 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0003 affected3,545 at risk EG0014 affected3,537 at risk
Foot fracture	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0000 affected3,545 at risk EG0011 affected3,537 at risk
Forearm Fracture	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0000 affected3,545 at risk EG0011 affected3,537 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0001 affected3,545 at risk EG0013 affected3,537 at risk
Humerus Fracture	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0000 affected3,545 at risk EG0011 affected3,537 at risk
Incisional hernia	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0000 affected3,545 at risk EG0011 affected3,537 at risk
Jaw fracture	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0000 affected3,545 at risk EG0011 affected3,537 at risk
Laceration	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0000 affected3,545 at risk EG0011 affected3,537 at risk
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0001 affected3,545 at risk EG0010 affected3,537 at risk
Multiple injuries	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0001 affected3,545 at risk EG0010 affected3,537 at risk
Nerve injury	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0001 affected3,545 at risk EG0010 affected3,537 at risk
Pelvic fracture	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0000 affected3,545 at risk EG0011 affected3,537 at risk
Perirenal haematoma	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0000 affected3,545 at risk EG0011 affected3,537 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0001 affected3,545 at risk EG0010 affected3,537 at risk
Postoperative adhesion	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0000 affected3,545 at risk EG0011 affected3,537 at risk
Radius fracture	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0000 affected3,545 at risk EG0011 affected3,537 at risk
Seroma	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0000 affected3,545 at risk EG0011 affected3,537 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0001 affected3,545 at risk EG0010 affected3,537 at risk
Spinal cord injury	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0000 affected3,545 at risk EG0011 affected3,537 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0001 affected3,545 at risk EG0010 affected3,537 at risk
Thoracic vertebral fracture	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0000 affected3,545 at risk EG0011 affected3,537 at risk
Tibia fracture	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0001 affected3,545 at risk EG0010 affected3,537 at risk
Traumatic liver injury	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0000 affected3,545 at risk EG0011 affected3,537 at risk
Wound dehiscence	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0000 affected3,545 at risk EG0011 affected3,537 at risk
Wrist fracture	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0002 affected3,545 at risk EG0010 affected3,537 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment	EG0001 affected3,545 at risk EG0011 affected3,537 at risk
Diabetes Mellitus	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment	EG0005 affected3,545 at risk EG0012 affected3,537 at risk
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment	EG0002 affected3,545 at risk EG0012 affected3,537 at risk
Diabetic foot	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment	EG0002 affected3,545 at risk EG0011 affected3,537 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment	EG0000 affected3,545 at risk EG0011 affected3,537 at risk
Electrolyte imbalance	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment	EG0001 affected3,545 at risk EG0010 affected3,537 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment	EG0002 affected3,545 at risk EG0011 affected3,537 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment	EG0000 affected3,545 at risk EG0011 affected3,537 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment	EG0002 affected3,545 at risk EG0010 affected3,537 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment	EG0000 affected3,545 at risk EG0011 affected3,537 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment	EG0000 affected3,545 at risk EG0011 affected3,537 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment	EG0000 affected3,545 at risk EG0011 affected3,537 at risk
Malnutrition	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment	EG0000 affected3,545 at risk EG0011 affected3,537 at risk
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment	EG0003 affected3,545 at risk EG0010 affected3,537 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment	EG0003 affected3,545 at risk EG0013 affected3,537 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment	EG0003 affected3,545 at risk EG0010 affected3,537 at risk
Arthropathy	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment	EG0001 affected3,545 at risk EG0010 affected3,537 at risk
Costochondritis	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment	EG0001 affected3,545 at risk EG0010 affected3,537 at risk
Gouty arthritis	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment	EG0001 affected3,545 at risk EG0010 affected3,537 at risk
Intervertebral disc degeneration	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment	EG0000 affected3,545 at risk EG0011 affected3,537 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment	EG0000 affected3,545 at risk EG0013 affected3,537 at risk
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment	EG0001 affected3,545 at risk EG0011 affected3,537 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment	EG0007 affected3,545 at risk EG00112 affected3,537 at risk
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment	EG0000 affected3,545 at risk EG0011 affected3,537 at risk
Spinal column stenosis	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment	EG0001 affected3,545 at risk EG0010 affected3,537 at risk
Spondylolisthesis	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment	EG0001 affected3,545 at risk EG0010 affected3,537 at risk
Acute leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0001 affected3,545 at risk EG0010 affected3,537 at risk
Acute myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0001 affected3,545 at risk EG0011 affected3,537 at risk
Adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0000 affected3,545 at risk EG0011 affected3,537 at risk
B-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0000 affected3,545 at risk EG0011 affected3,537 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0001 affected3,545 at risk EG0010 affected3,537 at risk
Bladder adenocarcinoma stage unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0000 affected3,545 at risk EG0011 affected3,537 at risk
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0001 affected3,545 at risk EG0010 affected3,537 at risk
Bladder transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0002 affected3,545 at risk EG0010 affected3,537 at risk
Brain neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0001 affected3,545 at risk EG0010 affected3,537 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0001 affected3,545 at risk EG0013 affected3,537 at risk
Breast cancer stage II	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0001 affected3,545 at risk EG0010 affected3,537 at risk
Chronic myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0001 affected3,545 at risk EG0010 affected3,537 at risk
Colon adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0000 affected3,545 at risk EG0011 affected3,537 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0002 affected3,545 at risk EG0011 affected3,537 at risk
Gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0000 affected3,545 at risk EG0011 affected3,537 at risk
Gastrointestinal stromal tumor	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0000 affected3,545 at risk EG0011 affected3,537 at risk
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0001 affected3,545 at risk EG0011 affected3,537 at risk
Lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0001 affected3,545 at risk EG0010 affected3,537 at risk
Lung carcinoma cell type unspecified stage IV	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0001 affected3,545 at risk EG0010 affected3,537 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0000 affected3,545 at risk EG0011 affected3,537 at risk
Lung squamous cell carcinoma stage unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0000 affected3,545 at risk EG0011 affected3,537 at risk
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0001 affected3,545 at risk EG0010 affected3,537 at risk
Meningioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0001 affected3,545 at risk EG0010 affected3,537 at risk
Metastases to lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0000 affected3,545 at risk EG0011 affected3,537 at risk
Metastatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0001 affected3,545 at risk EG0010 affected3,537 at risk
Neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0000 affected3,545 at risk EG0011 affected3,537 at risk
Non-small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0001 affected3,545 at risk EG0010 affected3,537 at risk
Oesophageal carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0000 affected3,545 at risk EG0011 affected3,537 at risk
Ovarian adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0000 affected3,545 at risk EG0011 affected3,537 at risk
Ovarian cancer	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0000 affected3,545 at risk EG0011 affected3,537 at risk
Pancreatic carcinoma	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0000 affected3,545 at risk EG0011 affected3,537 at risk
Pancreatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0000 affected3,545 at risk EG0012 affected3,537 at risk
Prolymphocytic leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0000 affected3,545 at risk EG0011 affected3,537 at risk
Prostrate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0002 affected3,545 at risk EG0014 affected3,537 at risk
Rectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0001 affected3,545 at risk EG0010 affected3,537 at risk
Sarcoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0001 affected3,545 at risk EG0010 affected3,537 at risk
Squamous cell carcinoma of the cervix	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0000 affected3,545 at risk EG0011 affected3,537 at risk
Transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0002 affected3,545 at risk EG0010 affected3,537 at risk
Carotid artery disease	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0000 affected3,545 at risk EG0011 affected3,537 at risk
Carotid artery stenosis	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0001 affected3,545 at risk EG0011 affected3,537 at risk
Cerebellar infraction	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0001 affected3,545 at risk EG0011 affected3,537 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0003 affected3,545 at risk EG0012 affected3,537 at risk
Cerebral infraction	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0003 affected3,545 at risk EG0012 affected3,537 at risk
Cerebral ischaemia	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0000 affected3,545 at risk EG0011 affected3,537 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0004 affected3,545 at risk EG00110 affected3,537 at risk
Cerebrovascular disorder	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0008 affected3,545 at risk EG0013 affected3,537 at risk
Cervical myelopathy	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0000 affected3,545 at risk EG0011 affected3,537 at risk
Cervicobrachial syndrome	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0000 affected3,545 at risk EG0011 affected3,537 at risk
Convulsion	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0002 affected3,545 at risk EG0010 affected3,537 at risk
Dementia alzheimer's type	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0001 affected3,545 at risk EG0011 affected3,537 at risk
Dementia with lewy bodies	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0001 affected3,545 at risk EG0010 affected3,537 at risk
Embolic stroke	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0000 affected3,545 at risk EG0011 affected3,537 at risk
Guillain-barre syndrome	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0000 affected3,545 at risk EG0011 affected3,537 at risk
Haemorrhage intracranial	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0001 affected3,545 at risk EG0011 affected3,537 at risk
Headcahe	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0000 affected3,545 at risk EG0011 affected3,537 at risk
Hemiplegia	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0001 affected3,545 at risk EG0010 affected3,537 at risk
Ishaemic stroke	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0000 affected3,545 at risk EG0013 affected3,537 at risk
Metabolic encephalopathy	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0000 affected3,545 at risk EG0011 affected3,537 at risk
Radiculopathy	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0001 affected3,545 at risk EG0010 affected3,537 at risk
Ruptured cerebral aneurysm	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0001 affected3,545 at risk EG0010 affected3,537 at risk
Stroke in evolution	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0000 affected3,545 at risk EG0011 affected3,537 at risk
Subarachnoid hemorrhage	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0001 affected3,545 at risk EG0011 affected3,537 at risk
Syncope	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0004 affected3,545 at risk EG0014 affected3,537 at risk
Transient ischemic attack	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0003 affected3,545 at risk EG0012 affected3,537 at risk
Vertebrobasilar insufficiency	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0000 affected3,545 at risk EG0011 affected3,537 at risk
VIIth nerve paralysis	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0001 affected3,545 at risk EG0010 affected3,537 at risk
Confusional state	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0000 affected3,545 at risk EG0011 affected3,537 at risk
Mental status change	Psychiatric disorders	MedDRA	Non-systematic Assessment	EG0001 affected3,545 at risk EG0010 affected3,537 at risk
Azotemia	Renal and urinary disorders	MedDRA	Non-systematic Assessment	EG0001 affected3,545 at risk EG0010 affected3,537 at risk
Calculus ureteric	Renal and urinary disorders	MedDRA	Non-systematic Assessment	EG0001 affected3,545 at risk EG0010 affected3,537 at risk
Nephropathy	Renal and urinary disorders	MedDRA	Non-systematic Assessment	EG0001 affected3,545 at risk EG0010 affected3,537 at risk
Obstructive uropathy	Renal and urinary disorders	MedDRA	Non-systematic Assessment	EG0001 affected3,545 at risk EG0010 affected3,537 at risk
Renal Failure	Renal and urinary disorders	MedDRA	Non-systematic Assessment	EG0002 affected3,545 at risk EG0010 affected3,537 at risk
Renal Failure acute	Renal and urinary disorders	MedDRA	Non-systematic Assessment	EG0003 affected3,545 at risk EG0012 affected3,537 at risk
Renal failure chronic	Renal and urinary disorders	MedDRA	Non-systematic Assessment	EG0002 affected3,545 at risk EG0012 affected3,537 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA	Non-systematic Assessment	EG0000 affected3,545 at risk EG0011 affected3,537 at risk
Endometriosis	Reproductive system and breast disorders	MedDRA	Non-systematic Assessment	EG0001 affected3,545 at risk EG0010 affected3,537 at risk
Prostatomegaly	Reproductive system and breast disorders	MedDRA	Non-systematic Assessment	EG0000 affected3,545 at risk EG0011 affected3,537 at risk
Uterovaginal prolapse	Reproductive system and breast disorders	MedDRA	Non-systematic Assessment	EG0000 affected3,545 at risk EG0011 affected3,537 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected3,545 at risk EG0011 affected3,537 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected3,545 at risk EG0010 affected3,537 at risk
Asthmatic crisis	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected3,545 at risk EG0011 affected3,537 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG00010 affected3,545 at risk EG00114 affected3,537 at risk
Dyspnea	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0002 affected3,545 at risk EG0012 affected3,537 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected3,545 at risk EG0010 affected3,537 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected3,545 at risk EG0010 affected3,537 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected3,545 at risk EG0012 affected3,537 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0002 affected3,545 at risk EG0010 affected3,537 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0003 affected3,545 at risk EG0010 affected3,537 at risk
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected3,545 at risk EG0010 affected3,537 at risk
Pulmonary mass	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected3,545 at risk EG0010 affected3,537 at risk
Pulmonary edema	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected3,545 at risk EG0011 affected3,537 at risk
Respiratory arrest	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected3,545 at risk EG0010 affected3,537 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0002 affected3,545 at risk EG0013 affected3,537 at risk
Upper airway obstruction	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected3,545 at risk EG0010 affected3,537 at risk
Angioedema	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected3,545 at risk EG0010 affected3,537 at risk
Aneurysm ruptured	Vascular disorders	MedDRA	Non-systematic Assessment	EG0000 affected3,545 at risk EG0011 affected3,537 at risk
Aortic aneurysm	Vascular disorders	MedDRA	Non-systematic Assessment	EG0003 affected3,545 at risk EG0011 affected3,537 at risk
Aortic dissection	Vascular disorders	MedDRA	Non-systematic Assessment	EG0000 affected3,545 at risk EG0011 affected3,537 at risk
Aortic stenosis	Vascular disorders	MedDRA	Non-systematic Assessment	EG0000 affected3,545 at risk EG0011 affected3,537 at risk
Arteriosclerosis	Vascular disorders	MedDRA	Non-systematic Assessment	EG0001 affected3,545 at risk EG0011 affected3,537 at risk
Hypertension	Vascular disorders	MedDRA	Non-systematic Assessment	EG0008 affected3,545 at risk EG0018 affected3,537 at risk
Hypertensive crisis	Vascular disorders	MedDRA	Non-systematic Assessment	EG0004 affected3,545 at risk EG0012 affected3,537 at risk
Hypotension	Vascular disorders	MedDRA	Non-systematic Assessment	EG0002 affected3,545 at risk EG0011 affected3,537 at risk
Peripheral artery aneurysm	Vascular disorders	MedDRA	Non-systematic Assessment	EG0001 affected3,545 at risk EG0011 affected3,537 at risk
Varicose ulceration	Vascular disorders	MedDRA	Non-systematic Assessment	EG0001 affected3,545 at risk EG0010 affected3,537 at risk

ID	Term
D012141	Respiratory Tract Infections
D007239	Infections
D009976	Orthomyxoviridae Infections
D012327	RNA Virus Infections
D014777	Virus Diseases
D012140	Respiratory Tract Diseases

ID	Term
C478243	fluad vaccine
D007252	Influenza Vaccines

ID	Term
D014765	Viral Vaccines
D014612	Vaccines
D001688	Biological Products
D045424	Complex Mixtures

ID	Title	Description
BG000	aTIV (Pooled)	Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
BG001	Licensed TIV	Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	aTIV (Pooled)	Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).			264	3,545	1,678	3,545
EG001	Licensed TIV	Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).			243	3,537	1,257	3,537

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Chills	General disorders	MedDRA	Systematic Assessment	EG000258 affected3,545 at risk EG001176 affected3,537 at risk
Fatigue	General disorders	MedDRA	Systematic Assessment	EG000480 affected3,545 at risk EG001379 affected3,537 at risk
Injection site erythema	General disorders	MedDRA	Systematic Assessment	EG000292 affected3,545 at risk EG001255 affected3,537 at risk
Injection site pain	General disorders	MedDRA	Systematic Assessment	EG0001,172 affected3,545 at risk EG001643 affected3,537 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG000315 affected3,545 at risk EG001293 affected3,537 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG000536 affected3,545 at risk EG001360 affected3,537 at risk
Headache	Nervous system disorders	MedDRA	Systematic Assessment	EG000492 affected3,545 at risk EG001426 affected3,537 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG000186 affected3,545 at risk EG001172 affected3,537 at risk